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The CM team will be blinded until randomisation.
The assessor will be blinded until the comparative data analysis is conducted.
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Both the research team and participants will be blinded to randomization until the last participant has completed the protocol and the spreadsheets of all results are finalized.
The researchers will be blinded to group allocation until completion of the statistical analyses.
The trial statisticians and economists will be blinded to treatment allocation until analyses are complete.
The statistician will be blinded to group allocation until completion of the statistical analyses.
The assessor for final outcome measurements will be blinded to group allocation until the final assessment is achieved.
Outcome assessors and investigators involved in data analysis will be blinded to group assignment until analyses have been carried out.
To avoid bias, clinicians will be blinded to alcohol exposure until after they have scored and determined outcomes for facial anomalies, growth deficit and CNS abnormalities.
Researchers, caregivers, outcome assessors and a person responsible for the statistical analysis will be blinded to the intervention until a statistical report for the 12 months' developmental assessment is available.
We recognise that blinding of the operating surgeons to the assigned preventative strategy is not feasible given the different appearance of the CHG and povidone iodine; however, the operating surgeons will be blinded to the allocation until the day of surgery.
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